Company Highlights - Alnylam Pharmaceuticals had an active 2024, with a significant highlight being the positive results from the Phase III HELIOS-B study of Amvuttra (vutrisiran) in ATTR amyloidosis with cardiomyopathy (ATTR-CM) [1] Clinical Trial Results - The Phase III HELIOS-B study of Amvuttra (vutrisiran) showed very positive results in treating ATTR-CM, a key development for the company [1] Future Prospects - The potential impact of the HELIOS-B study results on the company's future remains to be seen, but it represents a significant milestone in its clinical pipeline [1]

Core Viewpoint - Alnylam Pharmaceuticals (ALNY) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changing earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling actions that affect stock prices [4]. Recent Performance and Projections - Alnylam is projected to earn -$0.39 per share for the fiscal year ending December 2024, reflecting an 88.9% year-over-year change [8]. - Over the past three months, the Zacks Consensus Estimate for Alnylam has increased by 19.3%, indicating a positive trend in earnings outlook [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - Alnylam's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10][11].

Alnylam Pharmaceuticals (ALNY) announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the label expansion of Amvuttra (vutrisiran) for review to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM). Amvuttra, an RNAi therapeutic, is ALNY’s lead drug, which is currently approved in the United States for treating adult patients with polyneuropathy of transthyretin-mediated (hATTR) amyloidosis. It is also marketed in the EU for treating hATTR amyloidosis in adult patients with ...

Core Viewpoint - Alnylam Pharmaceuticals reported a significant decline in total revenues and adjusted loss per share for Q3 2024, primarily due to reduced collaboration revenues, despite strong growth in net product revenues driven by new drug demand. Financial Performance - Adjusted loss of 50 cents per share, matching Zacks Consensus Estimate, compared to earnings of $1.74 per share in the same quarter last year [1] - Total revenues of $500.9 million, missing the Zacks Consensus Estimate of $529 million, and down 33% year over year from $750.5 million [2] - Net product revenues increased to $420.1 million, up 34% year over year, driven by strong demand for Amvuttra, Givlaari, and Oxlumo [3] Collaboration and Royalties - Net revenues from collaborators fell to $57.4 million, down 87% from the previous year due to reduced revenues from collaborations with Roche and Regeneron [3] - Royalty revenues increased to $23.4 million, up from $9.9 million in the year-ago quarter, driven by higher sales of Leqvio by Novartis [7] Product Performance - Amvuttra generated sales of $258.6 million, up 74% year over year, exceeding estimates [9] - Givlaari sales reached $71 million, reflecting a 31% increase year over year, also surpassing estimates [10] - Oxlumo recorded revenues of $40.2 million, a 40% increase year over year, but missed estimates [10] - Onpattro sales were $50.3 million, down 38% year over year, missing estimates [8] Expenses and Cash Position - Adjusted R&D expenses rose 12% year over year to $251.1 million, while SG&A expenses increased 19% to $195 million [11] - Cash, cash equivalents, and marketable securities amounted to $2.78 billion as of September 30, 2024, up from $2.62 billion as of June 30, 2024 [12] Guidance and Pipeline Updates - The company expects combined net product revenues for 2024 to be between $1.575 billion and $1.650 billion, with collaboration and royalty revenues anticipated in the range of $575 million to $650 million [13] - Regulatory applications for Amvuttra's label expansion to treat ATTR amyloidosis with cardiomyopathy have been submitted in the U.S. and EU [14]

·2 Alnylam Third Quarter 2024 Financial Results October 31, 2024 1© 2024 Alnylam Pharmaceuticals, Inc. Agenda Welcome • Christine Lindenboom Chief Corporate Communications Officer Overview • Yvonne Greenstreet, MBChB, MBA Chief Executive Officer Commercial Highlights • Tolga Tanguler Chief Commercial Officer Alnylam Pipeline • Pushkal Garg, M.D. Chief Medical Officer Financial Summary and Upcoming Milestones • Jeff Poulton Chief Financial Officer Q&A Session 2 Alnylam Forward Looking Statements This present ...

Financial Data and Key Metrics Changes - In Q3 2024, Alnylam Pharmaceuticals achieved a 34% year-over-year growth in global net product revenue, generating $420 million across its four marketed products [6][38] - Net revenue from collaborations decreased by $370 million compared to the previous year, primarily due to the recognition of a $310 million upfront payment from Roche in Q3 2023 [39] - Royalty revenue for the quarter was $23 million, more than double the amount recognized in Q3 2023, driven by higher sales of Leqvio [40] - Gross margin on product sales improved to 80% from 75% in Q3 2023, attributed to lower costs associated with canceled manufacturing commitments in 2023 [41] Business Line Data and Key Metrics Changes - The TTR franchise generated $309 million in global net product revenues, reflecting a 34% increase year-over-year [11] - The rare franchise, including GIVLAARI and OXLUMO, delivered $111 million in combined net product sales, representing an 8% increase compared to Q2 2024 and 34% growth compared to Q3 2023 [18] Market Data and Key Metrics Changes - In the U.S., combined sales of ONPATTRO and AMVUTTRA increased by 37% year-over-year, driven by a 31% increase in demand for AMVUTTRA [13] - Internationally, the TTR franchise grew by 31% year-over-year, despite a 9% quarter-on-quarter decrease due to gross to net adjustments [14] Company Strategy and Development Direction - Alnylam aims to establish its TTR portfolio as a flagship franchise, similar to EYLEA for Regeneron, to drive long-term growth and investment in R&D [7] - The company is focused on advancing its pipeline, with plans to file proprietary INDs for 9 programs by the end of 2025, targeting various disease areas [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the Alnylam P5x25 goals by year-end 2025, emphasizing a strong pipeline of first and/or best-in-class product candidates [9] - The management highlighted the significant unmet need in ATTR cardiomyopathy and the potential for vutrisiran to address this market upon regulatory approval [15][16] Other Important Information - Alnylam announced the decision to stop clinical development of ALN-KHK, focusing resources on more promising programs [35] - The company ended Q3 2024 with cash, cash equivalents, and marketable securities of $2.8 billion, an increase from $2.4 billion at the end of 2023 [45] Q&A Session Summary Question: Can you elaborate on the work done to improve RNAi delivery to adipose tissue and muscle? - Management highlighted the well-tolerated nature of RNAi therapeutics and the sustained knockdown of disease-causing proteins, guided by human genetics for disease validation [49][50] Question: Regarding ALN-HTT02, what are the expectations for Phase 1 data? - Management expressed excitement about the Huntington's program, emphasizing the potential for sustained knockdown and unique efficacy due to targeting the exon 1 fragment of the gene [54][56] Question: How has the second silencer impacted the market for polyneuropathy? - Management noted a 37% year-over-year growth in the U.S. for polyneuropathy treatments, indicating strong demand despite new competition [60][61] Question: What are the payer discussions regarding potential label expansion? - Management discussed the importance of clinical outcomes in payer discussions and the company's patient access philosophy, which aims to minimize co-pay burdens for patients [71][73] Question: How does the company view the potential for a bolus of patients seeking new treatments? - Management indicated that the fast progression of ATTR cardiomyopathy will lead to early diagnosis and treatment, positioning AMVUTTRA as a first-line therapy [82][84] Question: What are the expectations for the acoramidis label and its relevance to Alnylam's launch? - Management expressed confidence in their data from HELIOS-B and indicated that they are closely monitoring the acoramidis label [87][88] Question: How should spending levels in SG&A be viewed relative to the upcoming launches? - Management indicated an expectation of double-digit growth in SG&A as they prepare for the launches in both the U.S. and Europe [93] Question: What are the company's thoughts on potential business development activities? - Management emphasized the focus on internal pipeline growth while remaining open to opportunities that enhance their platform [102]

Core Insights - Alnylam Pharmaceuticals reported a significant decline in revenue for Q3 2024, with total revenue of $500.92 million, down 33.3% year-over-year, and an EPS of -$0.50 compared to $1.15 a year ago [1] - The reported revenue fell short of the Zacks Consensus Estimate of $529.34 million, resulting in a surprise of -5.37% [1] Revenue Performance - Net Product Revenue for Oxlumo in the U.S. was $14.93 million, slightly below the average estimate of $15.73 million, but showed a year-over-year increase of 53.7% [3] - Net Product Revenue for Amvuttra in the U.S. reached $168.66 million, exceeding the average estimate of $153.83 million, with a year-over-year growth of 48.6% [3] - Net Product Revenue for Givlaari in the U.S. was $40.37 million, below the average estimate of $42.96 million, but still represented a 9.1% increase year-over-year [3] - Net Product Revenue for Onpattro in the U.S. was $16.21 million, below the average estimate of $18.23 million, reflecting a year-over-year decline of 25.9% [3] - Total net product revenues amounted to $420.15 million, surpassing the 10-analyst average estimate of $414.11 million, with a year-over-year increase of 34.2% [3] - Royalty revenue was reported at $23.39 million, exceeding the average estimate of $22.32 million, marking a significant year-over-year increase of 136.1% [3] - Net revenues from research collaborators were $57.39 million, falling short of the average estimate of $96.03 million [3] Stock Performance - Alnylam's shares have returned +3.7% over the past month, outperforming the Zacks S&P 500 composite, which saw a +1% change [4] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [4]

Alnylam Pharmaceuticals (ALNY) came out with a quarterly loss of $0.50 per share in line with the Zacks Consensus Estimate. This compares to earnings of $1.15 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this RNA interference drug developer would post a loss of $0.74 per share when it actually produced earnings of $0.56, delivering a surprise of 175.68%.Over the last four quarters, the company has surpassed consensus EPS estimates three times.A ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________ FORM 10-Q ____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered Common Stock, $0.01 par value per share ALNY The Nasdaq Stock Market LLC For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 O ...

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, with the aim of buying high and selling higher, leveraging established price movements for profitable trades [1]. Company Overview: Alnylam Pharmaceuticals (ALNY) - Alnylam Pharmaceuticals currently holds a Momentum Style Score of A, indicating strong momentum characteristics [1]. - The company has a Zacks Rank of 2 (Buy), suggesting a favorable outlook based on historical performance metrics [2]. Performance Metrics - Over the past week, ALNY shares increased by 4.08%, outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 2.24% [3]. - In the last month, ALNY's price change was 9.4%, significantly higher than the industry's 1.44% [3]. - Over the past quarter, ALNY shares have risen by 26.8%, and they have increased by 80.82% over the last year, compared to the S&P 500's gains of 5.5% and 40.28%, respectively [3]. Trading Volume - ALNY's average 20-day trading volume is 740,644 shares, which serves as a bullish indicator when combined with rising stock prices [3]. Earnings Outlook - In the last two months, one earnings estimate for ALNY has increased while one has decreased, leading to a consensus estimate improvement from -$0.83 to -$0.64 [4]. - For the next fiscal year, one estimate has moved upwards, while three have been revised downwards [4]. Conclusion - Given the strong performance metrics and positive earnings outlook, ALNY is positioned as a solid momentum pick with a Momentum Score of A and a Zacks Rank of 2 (Buy) [4].